Aortic Valve StenosisLOWASNCT02727504
Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve
An observational study of Aortic Valve Stenosis, run by Rennes University Hospital at 1 site in France.
Trial summary
Investigators sought to demonstrate that the increase in the stroke volume during a dobutamine stress echocardiography might impact the prognosis of a patient addressed for a low flow low gradient suspected severe aortic valve stenosis. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Electrocardiogram, 2D and 3D echocardiography and Dobutamine stress echocardiography
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2016to 6 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with low flow low gradient aortic stenosis
Who may be able to join
- Patient from 45 to 90 years old
- Patient agreeing freely to participate in the study
- Aortic surface area suspected to be < 1 cm² or < 0.6 cms²/m²
- Low aortic gradient defined by a mean pressure gradient < 40 mmHg
- Aortic low flow defined by: a stroke volume indexed < 35 ml/m2
- Any contra-indication for the realization of the MRI
Who cannot join
- Heart rhythm disorders
- Presence of comorbidity altering the 2-year prognosis of a patient (cancer, terminal renal insufficiency (GFR 30 ml / min / 1,73m2), liver cirrhosis, respiratory insufficiency (VEMS 1 L)
- Presence of a concomitant valvular heart disease with stenosis or regurgitation > moderated
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Investigators sought to demonstrate that the increase in the stroke volume during a dobutamine stress echocardiography might impact the prognosis of a patient addressed for a low flow low gradient suspected severe aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Electrocardiogram, 2D and 3D echocardiography, Dobutamine stress echocardiography, Blood tests, Cardiac MRI
- Keywords
- Aortic valve stenosis, low flow, dobutamine stress echocardiography
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramDevice
ECG at inclusion and M12
2D and 3D echocardiographyDevice
2D and 3D echocardiography at inclusion and M12
Dobutamine stress echocardiographyDevice
dobutamine stress echocardiography at inclusion
Blood testsBiological
Blood test electrolytes, creatinine, hemoglobin, NT-proBNP, CRP, ST-2 at inclusion and M12
Cardiac MRIDevice
Cardiac MRI at inclusion
Cardiac scannerDevice
Cardiac scanner at inclusion
6-minutes walking testOther
6-minutes walking test at inclusion and M12
Duke Activity ScoreOther
Duke Activity Score at inclusion and M12
| Study group | Role | What they receive |
|---|---|---|
| Patient with aortic valve stenosis | 115 patients will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions.
Then will be performed :
* An electrocardiogram
* 2D and 3D echocardiography
* Dobutamine stress echocardiography
* Blood tests : blood electrolytes, creatinine, hemoglobin, N-terminal pro-brain natriuretic peptide (NT-ProBNP), C reactive protein (CRP), soluble suppression of tumorigenicity-2 (ST-2)
* A cardiac MRI
* A cardiac scanner
* A 6-minutes walking test
* An evolution of the Duke Activity Score Receives: Device: Electrocardiogram; Device: 2D and 3D echocardiography; Device: Dobutamine stress echocardiography; Biological: Blood tests; Device: Cardiac MRI; Device: Cardiac scanner; Other: 6-minutes walking test; Other: Duke Activity Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of death of all cause
Measured: Month 12
Number of emergent hospitalization for any cardiovascular reason
Measured: Month 12
Secondary outcomes (5)
Death (all causes)
Measured: 12 months
Emergency Cardiovascular hospitalization
Measured: 12 months
Change in left ventricular ejection fraction (LVEF), in global longitudinal strain in 2D and or 3D echocardiography
Measured: Inclusion, 12 months
Symptoms evolution
6-minute walking test
Measured: Inclusion, 12 months
Symptoms evolution
Duke Activity Score
Measured: Inclusion, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start11 May 2016
- Primary completion6 Jan 2020
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727504
- Sponsor's protocol ID
- 2015-A00896-43
- Other IDs
- 35RC15_9884_LOWAS
- Acronym
- LOWAS
- Status last verified
- Feb 2020
- First submitted
- 21 Mar 2016
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve
- ClinicalTrials.gov ID
- NCT02727504
- Acronym / sponsor ID
- LOWAS / 2015-A00896-43
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic valve stenosis, low flow, dobutamine stress echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 11 May 2016
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators sought to demonstrate that the increase in the stroke volume during a dobutamine stress echocardiography might impact the prognosis of a patient addressed for a low flow low gradient suspected severe aortic valve stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with aortic valve stenosis | – | Device: Electrocardiogram, Device: 2D and 3D echocardiography, Device: Dobutamine stress echocardiography, Biological: Blood tests, Device: Cardiac MRI, Device: Cardiac scanner, Other: 6-minutes walking test, Other: Duke Activity Score115 patients will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions. Then will be performed : * An electrocardiogram * 2D and 3D echocardiography * Dobutamine stress echocardiography * Blood tests : blood electrolytes, creatinine, hemoglobin, N-terminal pro-brain natriuretic peptide (NT-ProBNP), C reactive protein (CRP), soluble suppression of tumorigenicity-2 (ST-2) * A cardiac MRI * A cardiac scanner * A 6-minutes walking test * An evolution of the Duke Activity Score |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with low flow low gradient aortic stenosis
Key inclusion criteria (6 listed)
- Patient from 45 to 90 years old
- Patient agreeing freely to participate in the study
- Aortic surface area suspected to be < 1 cm² or < 0.6 cms²/m²
- Low aortic gradient defined by a mean pressure gradient < 40 mmHg
- Aortic low flow defined by: a stroke volume indexed < 35 ml/m2
Key exclusion criteria (4 listed)
- Heart rhythm disorders
- Presence of comorbidity altering the 2-year prognosis of a patient (cancer, terminal renal insufficiency (GFR 30 ml / min / 1,73m2), liver cirrhosis, respiratory insufficiency (VEMS 1 L)
- Presence of a concomitant valvular heart disease with stenosis or regurgitation > moderated
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrocardiogramECG at inclusion and M12 | Device | Patient with aortic valve stenosis |
| 2D and 3D echocardiography2D and 3D echocardiography at inclusion and M12 | Device | Patient with aortic valve stenosis |
| Dobutamine stress echocardiographydobutamine stress echocardiography at inclusion | Device | Patient with aortic valve stenosis |
| Blood testsBlood test electrolytes, creatinine, hemoglobin, NT-proBNP, CRP, ST-2 at inclusion and M12 | Biological | Patient with aortic valve stenosis |
| Cardiac MRICardiac MRI at inclusion | Device | Patient with aortic valve stenosis |
| Cardiac scannerCardiac scanner at inclusion | Device | Patient with aortic valve stenosis |
| 6-minutes walking test6-minutes walking test at inclusion and M12 | Other | Patient with aortic valve stenosis |
| Duke Activity ScoreDuke Activity Score at inclusion and M12 | Other | Patient with aortic valve stenosis |
Primary outcome
Number of death of all cause
Time frame: Month 12
Number of emergent hospitalization for any cardiovascular reason
Time frame: Month 12
5 secondary outcomes
Death (all causes)
Time frame: 12 months
Emergency Cardiovascular hospitalization
Time frame: 12 months
Change in left ventricular ejection fraction (LVEF), in global longitudinal strain in 2D and or 3D echocardiography
Time frame: Inclusion, 12 months
Symptoms evolution
Time frame: Inclusion, 12 months
Symptoms evolution
Time frame: Inclusion, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of death of all cause (time frame: Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.